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  • Cholera O1 Water Test Insert

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    Fuad Al-Awzari
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    28 views6 pages

    Cholera O1 Water Test Insert

    Uploaded by

    Fuad Al-Awzari

    Copyright:

    © All Rights Reserved
    Download as PDF or read online from Scribd
    Flag for inappropriate content
    of 6
    SMART™ Il CHOLERA 01 Water Test 10 Determinations Reorder No. 89-113210 A Colorimetric Immunoassay for Direct Detection of Vibrio cholerae 01 in Water NEW HORIZONS DIAGNOSTICS CORPORATION 9110 Red Branch Road Columbia, Maryland 21045 USA. email: NHDiag@aol.com 410/992-9357 / ax 410.992.0328 vA vu. vin ‘Table of Contents Tntended Use Page3 Introduction Page Principle ofthe Test. Page3-4 Materials Provided Page 4-5 Materials Required (but not provided) V.A Assembling Fiter Apparatus -Bage s Page 5 VB. Cleaning iter Apparatus Page 6 Storage and Stability 1 Page 6 Precautions Page 6 Specimen Preparation Page 6-9 ‘Test Procedure Page 9 Quality ConttOl snes Page 9-10 Results Page 10 Result Iastrations Page 10 Limitations Page 11 Expected Values Page 11 Performance Characteristics 1. Page 11-12 Page 12 Page 12 1. INTENDED USE Coles SMART™!I (Senaive Mentiine Aigen Rapid Tes) Wate Tet iss rapid, lal fw, colrineicmmuncssy designed when combi wih ‘lian regents fr prearton of war spl, for the dec prec fd gulnive deletion of Vivo cholerae Ot Wr spl, THe wt doves fan as be used to est Alkaline Peptone Water (APW) medium fom Moore Sas, asa confiputon of culture ress, ore a mony of presee> of 7 ‘ers 1 om ood species Nt fe Human use, 1. INTRODUCTION Chole epidemics, cused by V. chloe serotype O1, contin 10 be 2 Aevastang cease of ens loa since nan developing oars. inca, cholera may rang fom sympa colorization vevere dhe idk masive ld Tess, Teting to detain, cletolye distances, and {hath ¥ calerae OF ets ths eet Gate by collation of he sal, Ines end prduction of a potent col ein. Because ofthe cal and spidemiologealinporance of coir, Coker SMART I ust in apy Inching the geod of the octet in the environment in predicing the appearmes of cholera in an are, and in one te eetveness of pubic eh menae, The et cn abo edo confi cle rat, Coles SMART I user ltt How foot ad emonoclml sibs deed gin the" aigen of F.cfeae 01 LPS; thereby ecunventng he may Uther peoblens ensconced when polyeona!anOl unibody used 10 identify Fehloae 01 fom samples. The Chole SMART™ Itest simple, ‘and can be pecfomed in aprocnately 15 minutes, The lta ow Choe, SMART lay replace tho flow doug Cholera SMART uy, wich iz. a mooclna aniody~poyelonal anitodysandwvich aHouse fsting ‘Cholera SMART™ I a shown tobe uae to Cora SMART™ ML, PRINCIPLE OF THE TEST “The Cholera SMART™ TL assay rpc tein he aera low format. Basil, water samples (500 mi) ate cole into a Fitton ‘Devs (ot provided) and passed ough th ers povided in he Ki. Flor ‘removes lage petals, devs, nd oter materials With high flowrate, but very fw binding for 1 eholrae O1. Fir Beans escaaly 99% of ‘he ¥ cholerae OL wih a goo ow rat. Fier B is then placed ino tes ‘onsining APW sod inctted for 524 hours Using provided dropper, 3 ‘dopa tho sample Een the ieutted APW tube ae bansfered tothe (3) ‘Semple Well ofthe SMART II Choler Water devin, followed by Chase Buffer to eas the flow of angen fom () Sample Well to the (C) Cont SAR aon Wate few 8c Pge Line apd (1) Test Line An aevgenspeciic monoeons!eibodcouted colloidal gold pails (ecole) ae applied to a menbraesiface and ied. When 3 rps of an appropriately teed pcinen are squeezed ino te () sample well his ‘ried gold conjugte reals with ay tA. atigan that In present 3 it Inigets across the lengh of the membrane to wher it eneouniar eo Zones ‘of captre antibody (7) Test and (C) Convo Those aatboygold ‘conjugate whieh ve been Bound tothe eigen inthe sample are then Boul Inte F. cholerae OF expe antibody zone CP, pesenting a vsally ‘detectable tne of eolor and indctng postive test ret at (). Wf no ‘cholerae 1 presen, ie wl fan (7) athe supe wl oie fo Inigte to (C) the Positive Canol Lie (which & not specie forthe A niger and wl bind with any exces goi-cnjugtd antibody yeing ard Tae. "The () Line mast be vse wo ensi the device f workin propery. ‘Appearance of nen at (©) is inte of esample negative fer Fciterae ‘OL. Appearance of tvo lis, coe af (1) and one at (C) i nce of @ posve F colerae OF sample The ol et pron he et es thn omits, IV, MATERIALS PROVIDED. ach kit canine lowing is quanti sae to aequtely est 10 water samples st specified. Adena devies or aocesry reget can e obtained separately FON. POUCH: ‘ach fo posh conti ane SMARI™ I devi. CHASE BUFFER: Eachbttle of Cane blr contains processed te, dura and 0.08% sd ide (proseatie). POSITIVECONTROL ‘The botle of positive contol reagent contins REAGENT: beat nave ¥ ehaeras OL organisms inbuer, with 05% solu ake (reserva) ‘SPECIMEN FILTERING: ier A: Fie wih high fwsate an oy bacterial binding capacity ‘ler B: Fler wid high beter bindng capsity and igh bacteris oor. APW-TUDE: Conical patie contsining YL of akan pepions wate SAR Ch War DPCONTAMINATION REAGENT: Reagent 0X sation used to ‘scott the fier cambers between amples NEUTRALIZATION REAGENT: Reagents 10X soon uo realize the fier ese after desonuination PLASTIC ROPERS: Diposleplatc dope \V. MATDRIALS REQUIRED BUT NOT PROVIDED WITH KIT: “Tie flloning tems ae availble an acoso kt fom New Horizons Diagnosis Corporation 1) Fitering Devic, reuble veel ha uses 47 em laste itr and SO: of sample 2 Fores 3) Hand Pap Val ASSEMBLY OF THE FILTERING DEVICE (not provided): ‘The reas ter apparas supplied wih New Hortons Dingnostes Coportions accessory Kt fr wae sng consists of an pper and wet ‘chamber iter oie which fis ono te omer canker, sd ola hat ols the tr holder and upper ehanber tgs. ‘The lower camber xs two sie fms, ne of whic plod witha cap at coms wih he appre A zane tubing aarti on he second ie ws abo supplied wth the ‘hoe apes 1. Tovassenble the apparatus, pr te fier bole sgl onto tbe over harbor Plc he apron iter (Ao B) aioe op of te er hoe, Be siete fer st Ma and contre oo te itr bolder art overs Beene srfice are of the itr holder with no bucking ot va 2, Pace he calla ono the Fier holder nl sow the app canbe to thei ole by tinge col. 3. One sam shuld be scury fied wth dhe rubber sean cap, the second sidearm shoul be ited Wi te gad wublng adap. “Tubing hood seul ont the ade 44. Once samples been aed the upper chamber th oar end a he ‘bing shou be comected wih eter the hd pany (pid 8 & prt of NHD accor i) or an eter eau 00s ey cass V2. CLEANING THE FILTER APPARATUS (not provided) ‘The fie oppants should be cleaned with the detonation and einliton solos beaten mpi 1. Prepare woking solution of Decontamination Reaget by dting 5.0 snl 0X Decontamiatin Regen 50 lof water, Rao tho ter pra inling ail ictal pars hero. ‘Prepare 8 workin soliton of Newton Reagent by ang 5.0 of 10 Neataiation Reagent to 48 wl of water, Tho wae used for the prsperton of woikng Newlin Renget shld be known 0 tp fee of 7 sloroe O1. Rinse the fer appara aig all neal ps hroughy. 3. Stake excess water fiom he apart. Is now ready tobe usd fr there ene, ‘Vi. STORAGE AND STABILITY: CAUTION: DO NOT FREFZE! “The expat dt ofthe kts insted on tec box be end is based on ‘oper tmge ofthe components. Reagent canbe stored ether efigeatel or stom emperatre 2°C to 30°C cr 34°F 36). it. PRECAUTIONS ‘Suey precasonsshoud ke ose ining a cen roel ‘ethos wi yc miceboegelnil meas 2 ‘Aiea comin 0.09% sme Soi dag vt wi a ‘ed caper pnbig om «hy exsve meal ede. On pas oh Healy hee 3. These een oa nik, Do nt atte om ther iu 4 Dona ans teen the nda xan de, Sot ate ay ofthe eagans Ts wl tae hice otk on te ot tay ‘VIM, SPECIMEN PREPARATION ‘Te Li aed test dovice ean bowed to et arty of samples icing lea, abi ter contaminated e shige wis or APW ff Moore sms. The Sample pepution and procesing ssl ifferct fr eath of these te sample pes. Bath fp of water sup rue ton, “Te proce foe repaing samples Fr each of tese cases is docs belo. Tey 0506 ” Ad. Aa. As, As. As. As, an. BA ‘Clear potable water with minal debris o eontamination Collet we smples (300 mi) i cea container. Asseable the filter parts with Fer B ono the fer hole ws

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